NCT01731249已完成3 期
A Randomised, Double-blind, Placebo-controlled, Multi-national, Phase IIIb Study to Assess the Sustained Clinical Effect and Safety of Sublingual Immunotherapy Administered as Birch Pollen Extract Solution at a Dose of 300 IR Once Daily to Patients Suffering From Birch Pollen-induced Rhinoconjunctivitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 574
- 试验地点
- 22
- 主要终点
- Average Adjusted Symptom Score
研究概览
简要总结
The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the previous 2 pollen seasons requiring intake of symptomatic treatment.
- •Sensitization to birch pollen demonstrated by a positive Skin Prick Test to birch pollen with wheal diameter > 3 mm and birch pollen allergens specific IgE levels ≥ 0.70 kU/L.
- •RRTSS based on the previous or on the penultimate birch pollen season ≥ 12 out of a maximum possible score of
- •Patients with an FEV1 (Forced Expiratory Volume at one second) ≥ 80% of the predicted value.
- •Patients who are willing to comply with the protocol.
- •Patients having given a signed informed consent before completing any study related procedure.
排除标准
- •Patients with symptoms of rhinitis/rhinoconjunctivitis during the birch pollen season due to any other allergens (except alder and hazel). This includes patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study.
- •Patient who previously received desensitization treatment to birch pollen and/or another Betulaceae sp. (for example hazel or alder) within the previous 5 years.
- •Patients with ongoing treatment by immunotherapy with another allergen.
- •Pregnancy (positive pregnancy test), breast-feeding.
- •Female patients of childbearing potential planning a pregnancy during this study or not using a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner).
- •Patients planning to move during the study or planning to leave the area during the birch pollen season for more than 1 week (7 consecutive days).
- •Patients with moderate or severe persistent asthma (GINA 3 or 4).
- •Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents.
- •Patients with any nasal or oral condition that could interfere with the efficacy or safety assessments (such as nasal polyposis or oral inflammation).
- •Patients with severe immune deficiency.
- •Patients with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or outcome of this study.
- •Any other disease or condition which would place a patient at undue risk by being included in the study (according to the Investigator's opinion).
- •Usual contra-indications of immunotherapy such as concomitant beta-blocker therapy whatever the route and/or immunosuppressive drugs.
- •Patients treated with inhaled/systemic steroids (whatever the indication) within 4 weeks prior to Visit 1 (Screening), or with long acting systemic corticosteroids 12 weeks before Visit 1 (Screening).
- •Patients under continuous corticotherapy (inhaled or systemic drugs).
- •Patients following a strict low sodium diet as the study treatment contains 590 mg of sodium chloride per vial in a 10 mL solution.
- •Investigators, co-Investigators, as well as their children or spouses and all study collaborators.
结局指标
主要结局
Average Adjusted Symptom Score
时间窗: Year 2 of treatment
Symptom score adjusted on patient's rescue medication usage
次要结局
- Global evaluation of the efficacy by the patient(Year 2 of treatment)
- Average Rhinoconjunctivitis Total Symptom Score(Year 2 of treatment)
- Average Rescue Medication Score(Year 2 of treatment)
- Each of Six Individual Average Rhinoconjunctivitis Symptom Scores(Year 2 of treatment)
- Average Combined Score(Year 2 of treatment)
- Average Rhinoconjunctivitis Visual Analogue Scale Score(Year 2 of treatment)
- Average Adjusted Visual Analogue Scale Score(Year 2 of treatment)
- Rescue Medication Usage(Year 2 of treatment)
- Proportion of Symptom-controlled Days(Year 2 of treatment)
- Rhinoconjunctivitis Quality of Life Questionnaire(Year 2 of treatment)
- Sensitization profile(Before and after each treatment period (over 2 years))
- Asthma(Before, during and after each pollen season (over 2 years))
- Immunological markers specific for birch pollen(Before and after each treatment period (over 2 years))
- Economical Evaluation(Year 2 of treatment)
- Wheal diameter of the birch allergen Skin prick test(Before and after each treatment period (over 2 years))
- Oral Provocation Test(Year 2 of treatment)
- Mucosa Local Inflammation(Year 1 of treatment)
- Safety assessments(~20 months)
- Average adjusted Symptom score analysis by tertiles(Year 2 of treatment)
研究者
研究点 (22)
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